Trial of Single Agent Sunitinib for Patients With Chemo-refractory Metastatic Melanoma

NCT01216657 | Terminated Phase 2

• 1 other identifier: S379 SUMA
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Sunitinib is a novel small molecule receptor tyrosine kinase inhibitor with direct antitumor effects as well as antiangiogenetic activity. Preclinical and clinical data for Sunitinib and data about angiogenesis and growth regulation in melanoma suggest the activity of Sunitinib in melanoma. This study will investigate the efficacy, safety and tolerability of Sunitinib as palliative treatment in chemo-refractory metastatic melanoma.

Conditions

Chemo-refractory Melanoma

Keywords

melanoma; sunitinib

Outcome Measures

Primary Outcomes (2)

• clinical benefit rate cycle 1-3

  clinical benefit rate defined as a CR + PR + SD \> 4 months duration

  tumor assessment every 6 weeks

• clinical benefit rate cycle 4 and more

  clinical benefit rate defined as a CR + PR + SD \> 4 months duration

  tumor assessment every 12 weeks

Secondary Outcomes (4)

• response rate cycle 1-3

  tumor assessment every 6 weeks

• progression free survival

  follow-up one year

• overall survival

  follow-up for one year

• response rate cycle 4 and more

  every 12 weeks

Study Arms (1)

sunitinib

EXPERIMENTAL

50 mg Sunitinib daily for 4 weeks, then 2 weeks without treatment

Drug: Sunitinib

Interventions

Sunitinib DRUG

50 mg oral, daily, for 4 weeks, then 2 weeks without treatment, repeat at d43

sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 years and older.
• Diagnosis of unresectable (Stage III) or metastatic (Stage IV), histologically or cytologically proven, melanoma without clinically meaningful surgical or radiotherapeutical options except for mucosal or ocular origin of the primary tumor.
• Subjects must have completed a first or second line chemotherapy or be progressed under chemotherapeutic treatment. The previous treatment must have included DTIC alone or in combination
• Performance status of 0 to 2 on the ECOG scale
• Life expectancy \> 12 weeks.
• Patients must be able to swallow Sunitinib capsules.
• Evidence of measurable disease according to the RECIST criteria
• Prior radiation therapy allowed if completed at least 2 weeks and any major surgery allowed if completed at least 4 weeks prior to first dose of Sunitinib.
• Resolution of all acute toxic side effects of prior therapy or surgical procedures to grade \< 1 NCI-CTC (except for laboratory values).
• Adequate organ function including the following:
• platelets \> 100 x 109/L
• hemoglobin \> 8 g/dl
• absolute neutrophils count (AGC) \> 1.5 x 109/L.
• Hepatic:
• bilirubin \<=1.5 times upper limit of normal (ULN)

You may not qualify if:

• Prior treatment with ras-raf-MEK-ERK signaling pathway inhibitors (including trastuzumab, sorafenib, farnesyl transferase inhibitors or MEK inhibitors), or treatment with drugs which target VEGF (such as bevacizumab).
• Radiotherapy, except palliative radiotherapy during study participation as described.
• Known active infection (i.e. HIV, chronic hepatitis B or C, at the discretion of the investigator)
• History of organ allograft or stem cell transplantation.
• Coexisting second malignancy (excluding basal or squamous cell carcinoma of the skin, superficial bladder cancer and in situ carcinoma of the cervix with no evidence of recurrence) or history of prior malignancy
• Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (\> hemicolectomie or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis.
• Current history of chronic diarrhea defined as persisting diarrhea for more than 3 weeks at study entry due to any reason.
• Any of the following events prior to starting the trial treatment: \*clinically evident congestive heart failure, as defined by New York Health Association (NYHA) \> class II
• Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2
• Atrial fibrillation of any grade, or prolongation of the QTc interval to \>450 msec for males or \>470 msec for females.
• Subjects on beta-blockers and digoxin must be monitored closely
• QT-interval \> 450 msec
• Risk factors for torsade-de-pointes-tachycardia (i.e.. Hypokalaemia, congenital Long-QT-syndrome)
• Active coronary artery disease or ischemia (myocardial infarction within the last 6 months prior to study entry)
• Coronary/peripheral artery bypass graft

Sponsors & Collaborators

• Krankenhaus Nordwest: lead

Study Sites (1)

Krankenhaus Nordwest

Frankfurt am Main, 60488, Germany

Location

MeSH Terms

Conditions

Melanoma

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Elke Jäger, Prof. Dr.

  Krankenhaus Nordwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: October 7, 2010
• Study Start: March 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

DE (1)